Howmedica recalls Triathlon TS Plus Tibia Insert (model X3 POLY 11 MM) due to potential packaging breaches that could compromise sterility. Affected units sold between 2023-2028.
Potential packaging breaches of inner blister and outer sterile blister.
Howmedica is recalling its Triathlon TS Plus Tibia Insert (model X3 POLY 11 MM) because the packaging might not seal properly, risking contamination. This could affect surgical implants if the sterile packaging is compromised during use.
The packaging may breach, allowing contaminants to enter the sterile environment. This could lead to infection if the implant is not properly sterilized before use. However, the risk is low as this is a packaging issue, not a direct defect in the implant itself.
Surgical patients who received this specific implant model during procedures between 2023 and 2028. Patients using the product for orthopedic procedures are most at risk.
Check for the model name 'X3 POLY 11 MM' on the packaging. The product was sold with part number 5537-G-411-E and lot number E97TH6 between 2023 and 2028.
Inspect the inner and outer sterile blisters for signs of damage or breaches.
The recall is for potential packaging breaches, not a defect in the implant itself. If packaging is intact, the product may be safe.
Look for the model name 'X3 POLY 11 MM' on the packaging, part number 5537-G-411-E, and lot number E97TH6 with an expiration date of 10/07/2028.
The recall does not specify a return process, so contact Howmedica directly for guidance if you have concerns.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1264-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1264-2024 from Howmedica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
